NCT06122324

Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Evaluation of the Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Postoperative sore throat (POST) is a common outcome of general anesthesia in patients who undergo endotracheal intubation, and the estimated risk varies between 14.4% and 62%. It is one of the most undesirable postoperative anesthesia complications and has a negative impact on patient satisfaction and quality. Mucosal damage, inflammation, and erosion caused by endotracheal intubation all contribute to the development of POST. Therefore, POST is a condition that requires prevention and improvement. In the study, patients will be divided into two groups. The investigators will include 100 patients undergoing surgery under general anesthesia. The first group will receive 150 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive sterile distilled water as the control group. Throat pain assessment will be conducted in patients at 2, 6, 12, and 24 hours after surgery.

Detailed description

Between November 2023 and December 2023, a total of 100 patients aged 18-65 with ASA 1-3 classification who are electively scheduled for laparoscopic cholecystectomy will participate in the study. Patients with ASA 4 or higher, those aged 65 and older, those under 18, and individuals with a known allergy to local anesthesia will not be included in the study. Patients who require intubation and are admitted to the intensive care unit or who experience mortality will be excluded from the study. All patients will undergo preoperative assessment one day before the surgery, and written informed consent will be obtained for participation in the study. Patients will be randomly assigned to groups using a computer-generated randomization table. Patients in Group 1 will receive 150 mg (1,5ml) of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive terile distilled water (1,5ml) as the control group. Demographic data, medical history, American Society of Anesthesiologists (ASA) classification, and pre- and post-lidocaine administration cardiac output (CO) and oxygen consumption (VO2), anesthesia time, surgical duration, as well as the occurrence of postoperative hypotension (systolic blood pressure decreased by more than 20% from baseline or SBP \< 80 mmHg during surgery), nausea and vomiting, hypoxemia (SpO2 \< 90% or PaO2 \< 60 mmHg), hypercapnia (PaCO2 \> 45 mmHg), and agitation during the awakening period will be recorded. Throat pain will be assessed and recorded at postoperative hours 2, 6, 12, and 24. Throat pain will be evaluated using a throat pain scoring system ranging from 0 (no pain) to 3 (worst imaginable pain). After the surgery, all patients will be transferred to the post-anesthesia care unit (PACU).

Conditions

• Postoperative Sore Throat

Interventions

Type	Name	Description
DRUG	Lidocaine Hydrochloride	Patients in Group 1 will receive lidocaine HCl solution 5 minutes before endotracheal intubation.
DRUG	Drug (Placebo)	Sterile distilled water (1.5 mL) administration 5 minutes before intubation.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-01
• Completion: 2024-06-30
• First posted: 2023-11-08
• Last updated: 2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)